Dysmenorrhea is the medical term used to describe pain experienced immediately before or during menstruation. The pain is usually in the pelvis or lower abdomen. Other symptoms may include back pain (typically lower back), diarrhea, or nausea. While pelvic pain may be caused by other reasons, such as and not limited to appendicitis, kidney diseases, intestinal disorders, nerve conditions, and others; in primary and secondary dysmenorrhea pain is usually felt in the lower abdomen or back. Dysmenorrhea is a major problem affecting millions of women in the US alone. The condition is believed to be one of the largest contributors to absence of women from schools, work, and social engagements, among others. Medications, such as those taken orally, to treat dysmenorrhea are known to have undesired side effects.
TENS (Transcutaneous Electrical Nerve Stimulation) devices are well known and have been disclosed as being useful in treating a variety of indications. However, conventional TENS devices are difficult to place, activate, or maintain the TENS device on her own. Additionally, the TENS device must be configured to store, deliver, and maintain a substantial current density and/or power level, which results in a large profile and difficult to wear device.
Conventional devices typically only allow for powering on to start stimulation and powering off by manual manipulation of a switch and do not allow for automatic stimulation based on sensed data or triggers without on-going management by a user. Further, prior approaches using electrical, external stimulation to treat dysmenorrhea do not have a combination of the following characteristics effective to enable a patient to independently administer the device and accompanying therapies: wearability; administration by the patient; real-time or near real-time feedback from the patient (e.g. menstrual calendar, general well-being of the wearer, others) or from wearable devices, for example, a device, with physiological sensors, configured to be worn on the human body, such as around the wrist, in order to monitor, acquire, record, and/or transmit the physiological data; the ability to stimulate multiple times per day or week; daily, or on-demand, feedback from the device to the patient; storage of stimulation parameters and other real-time inputs; and an electrical stimulation profile and a footprint conducive to long term wearability. In addition, prior art therapies which have some degree of flexibility include an electrode which must be tethered via cables to a control or power box. Prior art therapies which are wireless are typically bulky, inflexible, and not amenable to being worn for long periods of time.
Also known are electro-acupuncture techniques that are influenced by acupuncture theory of the meridians, energy channels, and their distribution for a choice of sites or accupoints to be stimulated with electricity. Electro-acupuncture and specifically, accupoint stimulation, has been generally accepted for pain relief, but are not easily managed by a patient.
Therefore, there is a need for a low profile, long lasting electrical neuro-stimulation device which is programmed, and is effective to, manage primary and secondary dysmenorrhea, and specifically menstrual pain, with minimal habituation. There is also a need for a device that can effectively integrate a patient's well-being data, menstrual calendar, and other personal information.
There is a need for an electrical neuro-stimulation device which is wearable and can be controlled, programmed, and administered by the patient, thereby enabling greater patient independence. There is also a need for an electrical neuro-stimulation device which includes real-time or near real-time feedback from patient parameters including, but not limited to, exercise, diet, hunger, appetite, well-being, menstrual calendar, intake of birth-pills, and which will be able to obtain real-time or near real-time feedback from other wearable devices, for example, a device, with physiological sensors, configured to be worn on the human body, such as around the wrist, in order to monitor, acquire, record, and/or transmit the physiological data, allowing for frequent adjustability and customization of therapy to suppress menstrual pain. There is a need for an electro-stimulation device configured to intelligently trigger and initiate stimulation automatically and without on-going management by a user. There is a need for an electrical neuro-stimulation device having the ability to modify stimulation strength and frequency based on a patient's requirement. In addition, there is a need for an electrical neuro-stimulation device capable of storing stimulation parameters and other real-time inputs, such as diary and menstrual calendar, to provide a physician and the patient with real-time records and treatment profiles. The storage would include inputs from the electrical neuro-stimulation device and from other sources of information, for example, a device, with physiological sensors, configured to be worn on the human body, such as around the wrist, in order to monitor, acquire, record, and/or transmit the physiological data.
There is also a need for an electrical neuro-stimulation device which targets menstrual pain management, does not require implantation, and does not require wires or remote electrodes to provide stimulation. There is also a need for a patient-administered, wearable electrical neuro-stimulation directed toward suppressing pain and affecting prostaglandin levels. There is a need for an electrical neuro-stimulation device having a size, shape, weight, and being composed of materials all supported by power requirements as driven by stimulation therapy, allowing the device to be wearable. Such a device would eliminate the need for heavy stimulation parameters requiring heavy power needs (which would make wearability impractical or impossible). There is also a need for an electrical neuro-stimulation device which is controllable by a companion device (such as a smartphone) and includes no visible or tactile user interface on the stimulation device itself. There is a need for an electrical neuro-stimulation device having unique electrical stimulations and ‘footprints’, based on electrode design and stimulation parameters, which would allow using technology other than TENS.